Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description

Palacos® R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522
The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Recall Number

Z-0730-2014

Classification

Class II

Code Info

Cat No. 00-1113-140-01; lot 75974340

Product Distributed Qty

1,534 units

Reason For Recall

The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.